Drug Profile

Sibeprenlimab - Visterra

Alternative Names: VIS-649

Latest Information Update: 16 Jun 2025

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At a glance

Originator Visterra
Class Monoclonal antibodies; Urologics
Mechanism of Action B cell activating factor inhibitors; Tumour necrosis factor ligand superfamily member 13 inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes
Available For Licensing Yes

Highest Development Phases

Preregistration IgA nephropathy

Most Recent Events

06 Jun 2025 Efficacy and adverse event data from the phase III VISIONARY trial in IgA nephropathy released by Otsuka Pharmaceutical
27 May 2025 US FDA accepts Biologics License Application for Sibeprenlimab for priority review in IgA nephropathy
27 May 2025 US FDA assigns PDUFA action date of (28/11/2025) for Sibeprenlimab for IgA nephropathy

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